The present invention relates to a plaster device for fixating a length of a medical tube in relation to a skin surface of a patient having said tube inserted into a body part via an opening in the skin surface.
The plaster device is of the kind including an adhesive part having an upper side, an adherent lower side for attaching the plaster device to the skin surface, and a through-opening for receiving the tube, a support part partly attached to the upper side of the adhesive part and arranged for supporting a bent length of said inserted tube, and fastenings means for securing the tube on the support part.
Medical tubes are often introduced into a wound, a cavity or an organ of a human or animal body to facilitate sustained drainage or sustained supply of liquid or gaseous substances.
Examples of medical tubes used for drainage include, but are not limited to, a chest drainage tube, a lumpectomy or a mastectomy drainage tube, a renal drainage tube for use in e.g. dialysis or percutaneous nephrostomy, and a drainage tube for emptying e.g. an encystment or an abscess.
Examples of medical tubes used for supplying a substance to the patient include, but are not limited to, tubes and catheters for controlled administration of palliatives, such as analgesia, and hormones, such as insulin, delivered via e.g. an insulin pump.
Proper securing of the medical tube at and in relation to the patient's skin is necessary to improve the patient's comfort during the treatment. It is of outmost importance to avoid contamination of the puncture site, to avoid dislodgement of the tube, e.g. during inspection of the puncture site or during the patient moving, and to avoid kinking, blocking or obstruction of the tube to prevent discontinuity of drainage or supply.
Traditionally, a medical tube, inserted into the patient through an incision in the skin, is fixated by means of sutures at the incision site. Such sutures leaves scars and may even serve as wicks for undesirable contamination of the incision and the skin around the incision site. To prevent such contamination and to improve securing of the tube, a plaster strapping can be attached to both the skin and around the tube adjacent the incision.
Several approaches have been made to improve this securing technique, which is very distressing to the patient. Nowadays, more sophisticated techniques are used due to improved plaster devices and skin-friendly adhesives.
An improved catheter retainer has been suggested in British patent document GB 2,288,530. The retainer can be adhesively secured to a patient's skin at the incision site to hold an introduced catheter in a fixed position. The retainer allows the catheter to be bent through a right angle as the catheter exits the patient without it kinking The catheter is kept in place in the bent position in a slot by means of a clamp, which compresses and clamps the catheter into the slot. This device has uncomfortable rigid parts protruding from the patient's skin and the patient's clothes may be caught on the clamp, which accordingly will release the catheter. Another disadvantage is that it is impossible to inspect the incision site and consequently it is impossible to obtain information regarding infection at the site and/or leakage through the incision.
A plaster device without any substantially rigid parts is known from International patent application WO 95/33508. This known device has a plaster component for attaching the device to the skin of the patient and a support component for supporting a tube inserted into the patient's body via an incision in the skin. The tube is supported on the support component such that the tube changes orientation from an orientation substantially perpendicular to the patient's skin to an orientation substantially parallel to the patient's skin. The tube is fixated in this bent use-position by means of an adhesive securing strip applied sealingly over the tube and the support component. It is possible to inspect the tube and the site of the incision if the securing strip is transparent. However, it is impossible to obtain a reliable and convincing overview of the condition around the entire site of incision without removing the securing strip. Since the tube is not sutured to the incision site it is difficult to ensure that the tube is not displaced during removal of the adhesive securing strip. Consequently, this manipulation of the securing strip may displace the tube resulting in discomfort for the patient. In addition, the tube is covered with adhesive residues and will inadvertently stick to any adjacent component. Due to this disadvantage, the nurse is not inclined to perform as many inspections as are needed in order to be completely sure that e.g. no bleeding, infection or allergic reaction appears around the incision site, a part of which is hidden by the bent tube.
This prior art document further discloses an alternative embodiment proposing a securing strap or tie for fixating the tube in the use-position. The support part of this embodiment consists of three individual elements: two side elements of a soft foamed material attached on each side of a central element of a hard or rigid foamed material. A groove serving for preventing displacement of the tube is defined by the upper side of the central element and the sides of the side elements adjacent the central element. The combined support part is attached to the underlying plaster component so that the securing strap is arranged around the central element. This structure has the disadvantage that during tightening of the strap, there is a risk that the central element will be detached from any of the elements surrounding it and as a consequence destroy the entire structure. Since the bent tube is situated in the groove the tie strap is only provided for keeping the tube down in the groove and cannot prevent the tube from moving in the lengthwise direction of the support part. Also the free end of the securing strap is provided with barbs to in an awkward and inconvenient manner non-releaseably locking with an eye provided on the opposite end of the tie to create a locking loop. Just as a cable tie the created loop needs to be cut to gain access to the cables/tube that are held in place by the tie/strap. Another disadvantage of the strap of the device disclosed in WO 95/33508 is that once the free end of the tie strap is passed through the eye this free end sticks out at the risk of getting caught and withdrawn from the plaster thereby pulling the tube out of the groove and eventually out of the incision and body cavity into which the tube is inserted. If the free end is cut off only the barbs hold the strap closed which may be insufficient to resist exterior force applied to the strap when the patient moves around.
From European patent EP 0 463 718 B1 is known a catheter retainer as a means to avoid stitching of the catheter to the skin of the wearer. EP 0 463 718 B1 discloses a plaster device having protruding ears. The catheter is exteriorised between said ears and at a very short section the catheter is secured to the ears by means of a thread. The thread is wound around both the ears and the catheter using a number of winds to make sure that the catheter is not displaced when the patient moves. The use of this known device includes a considerable risk that the thread gets tangled up during winding and as a result the thread is complicated to unwind. Moreover, when arranging the thread around the catheter care must be taken not to clamp the catheter together. To avoid this often a rather loose winding is applied to the catheter resulting in that the catheter can slide back and forth with great discomfort to the patient as a result. Moreover this known device does not provide support for a bent length of a tube.
Accordingly, there is a need for improved plaster devices to overcome the deficiencies of the prior art, and these are now provided by the present invention.